Food, drugs, devices › Ortho-Clinical Diagnostics
Device recall: The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Re
FDA enforcement event 74009 is a device recall by Ortho-Clinical Diagnostics of Rochester, NY, initiated 19 Apr 2016 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 8 Jun 2018. Initiation: voluntary: firm initiated. Ortho-Clinical Diagnostics has 105 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ortho-Clinical Diagnostics, Rochester, NY.
Reason for recall
"There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay."
Distribution
"Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, WA, WV & Puerto Rico;** Foreign:…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2804-2016 | The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry… | 520 Units | Class III | Terminated | 21 Sep 2016 |
Context
Other enforcement events for Ortho-Clinical Diagnostics
All 105 events for Ortho-Clinical Diagnostics
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, WA, WV & Puerto Rico;** Foreign:…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Jun 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.